Bard Peripheral Vascular Recalls POWERPORT ClearVUE Implantable Ports
Bard Peripheral Vascular Inc is recalling 181 POWERPORT ClearVUE Slim catheters because the included Patient ID Card has incorrect flushing instructions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall. The hazard involves incorrect instructions on packaging rather than a direct defect in the device itself, which aligns with moderate severity criteria for labeling or instruction errors.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has announced a Class II recall of the POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes (REF 5678301). The product is manufactured by Bard Peripheral Vascular Inc.
The recall was initiated because the Patient ID Card packaged with the implantable port contains incorrect instructions for flushing the device. This issue affects 181 units distributed nationwide.
Affected lot numbers include REAN0061, REAP0772, REAT1524, REAV1479, REAV1938, REAW0937, REAW1186, REAW1666, REAY0528, REAY0795, REAZ1529, REBN0024, REBN1581, REBQ0210, REBS1277, REBR1125, REBS1395, REBS2412, REBT1785, REBT2349, REBU0563, REBV0760, and REBW1037. Each lot is identified by its Unique Device Identifier (UDI) code.
Consumers who possess this specific implantable port should check their Patient ID Card for the incorrect flushing instructions and contact their healthcare provider or Bard Peripheral Vascular Inc for further guidance.
The recalled product
- Product
- POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 181
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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